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FGL2/Fibroleukin and Hepatitis C Virus Recurrence Post Liver Transplantation

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00701272
First received: June 18, 2008
Last updated: July 24, 2013
Last verified: July 2013

June 18, 2008
July 24, 2013
June 2008
December 2014   (final data collection date for primary outcome measure)
serum FGL2 levels [ Time Frame: various time points ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00701272 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
FGL2/Fibroleukin and Hepatitis C Virus Recurrence Post Liver Transplantation
FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of HCV Recurrence and Progression Post Liver Transplantation

The main objective of this study is to assess whether a recently-developed bioassay for the molecule "secreted fibrinogen-like protein 2" (sFGL2) can be used to predict the recurrence and/or progression of Hepatitis C Virus disease in post liver transplant patients. The hypothesis is that patients with chronic HCV have higher than normal levels of sFGL2 in their blood both pre- and post-transplantation and that this will inhibit their ability to clear HCV, and influence the progression of HCV disease when it recurs.

Hepatitis C Virus infection (HCV) is a serious health problem worldwide, accounting for significant morbidity and mortality. The current treatment, combination therapy with pegylated IFNa/ribavirin results in only a 50% sustained viral response such that HCV is now the leading indication for liver transplantation. Unfortunately, HCV recurrence post-transplantation is universal and it is often difficult to distinguish recurrent HCV from other processes such as rejection, leading to inappropriate or delayed treatment(s) and compounding graft damage. It would be beneficial to have access to a circulating biomarker to distinguish HCV disease recurrence from other processes and to predict the severity of HCV disease progression post-transplantation.

The molecule FGL2 is secreted by cells of the immune system and may be a key immunomodulator affecting graft survival and HCV recurrence. The aim of this study is to assess whether a bioassay for FGL2 can predict HCV disease recurrence and progression after liver transplantation and/or differentiate HCV disease recurrence from acute cellular rejection.

This study will also examine the form of Fc Receptor expressed in these patients. The Fc receptor is hypothesized to be the binding partner of FGL2.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples; liver biopsy tissue

Non-Probability Sample

Individuals undergoing liver transplantation due to end-stage liver disease caused by Hepatitis C Virus or alcoholic cirrhosis

  • Liver Transplantation
  • Hepatitis C
Not Provided
  • 1
    Patients undergoing liver transplant for end-stage liver disease due to Hepatitis C
  • 2

    Control population:

    Patients undergoing liver transplantation for end-stage liver disease due to alcoholic cirrhosis


*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
70
December 2014
December 2014   (final data collection date for primary outcome measure)

For HCV positive subjects:

Inclusion Criteria:

  1. Able and willing to give written informed consent
  2. Willing to follow the study protocol
  3. Diagnosis of chronic HCV infection based on two positive serology tests
  4. No history of active alcohol or drug abuse
  5. All six viral genotypes are considered
  6. Pre- and post transplant viral load data must be available

Exclusion Criteria:

  1. Pregnancy
  2. HBV, HDV or HIV co-infection

For Non-HCV subjects:

Inclusion Criteria:

  1. Able and willing to give written informed consent
  2. Willing to follow the study protocol

Exclusion Criteria:

1. Free from infection by any of the following: HCV, HBV, HDV or HIV.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00701272
08-0385-T
No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Gary Levy, MD University Health Network, Toronto
University Health Network, Toronto
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP